FDA approves first treatment for giant cell arteritis.
THE FOOD AND DRUG Administration has approved subcutaneous tocilizumab (Actemra) for the treatment of giant cell arteritis.
Tocilizumab, an interleukin-6 receptor antagonist, is the first drug specifically indicated for giant cell arteritis. The standard treatment has typically been high doses of corticosteroids, tapered over time.
"We expedited the development and review of this application because this drug fulfills a critical need for patients with this serious disease who had limited treatment options," Badrul Chowdhury, MD, PhD, director of the division of pulmonary, allergy, and rheumatology products in the FDA's Center for Drug Evaluation and Research said in the announcement.
Approval was based on results from a double-blind, placebo-controlled study of 251 patients with giant cell arteritis. After 1 year, patients who received tocilizumab and tapered prednisone achieved remission at a higher rate than did patients who received placebo and tapered prednisone. Safety was consistent with tocilizumab's known safety profile.
Subcutaneous tocilizumab is also approved for moderate to severely active rheumatoid arthritis. The intravenous formulation is approved for the treatment of moderate to severely active rheumatoid arthritis, systemic juvenile idiopathic arthritis, and polyarticular juvenile idiopathic arthritis.
The FDA granted both Breakthrough Therapy and Priority Review designations to this supplemental new drug application of tocilizumab.
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|Date:||Jul 1, 2017|
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